Selective Versus Routine Shunting in Carotid Endarterectomy Patients

This study has been completed.

Sponsor:

CAMC Health System

ClinicalTrials.gov Identifier:

NCT00967486

First Posted: August 28, 2009

Last Update Posted: October 24, 2013

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The primary objective of this investigation is to determine through a prospectively randomized method whether a SP >= 50 mm Hg can be used as a threshold to indicate the need for selective carotid shunting during CEA under GA. [ Time Frame: Within 30 days of enrollment ]

A secondary objective is to document and measure the outcomes (death, minor stroke, major stroke, trans-ischemic attach (TIA)) that result from selective shunting. [ Time Frame: Within 30 days of enrollemnt ]

The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups.

Detailed Description

The significance extends to all surgeons who perform Carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it.

The hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid endarterectomy with a SP of > 50 mm Hg using selective shunting.Patients will be randomized to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is < 40mmHg calling it as Shunt group. All patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. The patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (TIA).